If a pharmaceutical manufacturer recalls a product due its potential dangers, it often takes several months or years for the public to become aware of how much the company knew beforehand and when they became aware of the danger. Too often, manufacturers participate in the act of concealing pertinent information, delaying their findings to the public and hoping the situation goes unnoticed.
The New England Compounding Center (NECC) is under criminal investigation for shipping 17,000 vials of a contaminated steroid pain medication to 23 states. To date, the steroid medication has killed 48 Americans and sickened over 700 more. Hundreds of people continue to fight severe infections, while the most recent death was reported one week ago. The incident is considered the worst pharmaceutical disaster in decades.
Whistleblower Speaks Out
On March 10, 60 Minutes anchor Scott Pelly interviewed Joe Connolly, whistleblower, insider and former NECC lab tech, who says he warned his supervisor at the New England Compounding Center that their drugs were going to harm people one month before a medication they produced began to kill patients. Connolly tells Pelly that the center supervisor, who is also under criminal investigation, simply dismissed his concerns.
“The underlying factor is that the company got greedy and overextended and we got sloppy, and something happened. We became a manufacturer overnight,” says Joe Connolly. “So we were basically trying to have the best of both worlds. It was trying to manufacture without the oversight of a manufacturer. And it was just — we all got over-taxed and everything.”
Until now, no one from the NECC attempted explain what went wrong during the manufacturing process. In fact, Barry Cadden, NECC president, took the Fifth Amendment when subpoenaed by Congress. When asked questions before the Congressional panel, Cadden responded by saying, “I respectfully decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment to the United States Constitution.” It was not until recently that whistleblowers began coming forward and speaking about what happened at NECC.
Charges Against NECC
US Attorney Carmen M. Ortiz acknowledged in a statement that she is probing New England Compounding, but has declined further comment. Agents from the US Food and Drug Administration’s Office of Criminal Investigations are also combing through the company’s Framingham,Massachusetts offices for evidence.
“If there is a federal charge, there is probably going to be jail time,” said Todd Graves, a former Missouri US attorney who prosecuted Kansas City pharmacist Robert Courtney in 2002 on several federal counts related to diluting chemotherapy drugs for thousands of cancer patients.
Graves, other former federal prosecutors and legal specialists all agree that the US Attorney’s Office is likely to focus on some specific charges against New England Compounding Center. The first of these charges are selling adulterated (contaminated) drugs in violation of the federal Food, Drug and Cosmetic Act. Secondly, the US Attorney’s office is likely to pursue charges of fraud and multiple violations of the False Claims Act. Both the fraud and False Claims Act charges stem from NECC defrauding Medicare and Medicaid through the sale of unsafe medications to thousands of hospitals and pain clinics nationwide who, in turn, billed the government for treatment of patients insured through these programs. The penalties for these charges range from a maximum of three to 20 years in prison, though federal guidelines allow for a life sentence in cases of health care fraud that involved a death.
A History of Violations
Federal regulators investigated NECC over a decade ago after patients treated with their injectable steroid began to complain of health problems. Many complaints included the same medication that is implicated in the current outbreak. The FDA also sent NECC a warning letter in 2006 in relation to mass-producing drugs and operating like a manufacturer, which state officials said violated its state license.
Investigators will be interviewing witnesses including the whistleblowers as well as former and current NECC employees and obtaining and reviewing internal documents and correspondence to show that NECC had knowledge that its compounded products/drugs were not sterile and failed to disclose this to regulators and the public, said Shauna Itri current attorney representing employees in whistleblower cases against their former companies.
Legal experts also anticipate a mass number of lawsuits as the outbreak continues to unfold, along with additional testimony from whistleblower insiders. Cases have already been filed in Florida, Massachusetts, Michigan, Minnesota, New Jersey, Tennessee and Virginia. While these include several class-action lawsuits, the bulk of cases are likely to be filed against the New England Compounding Center itself. Some lawsuits are also being filed against the clinics that administered the contaminated steroid injections to patients.
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